The Tufts Center for the Study of Drug Development reports that since 2000 the number of therapeutic peptides in clinical trials has nearly doubled due largely to advances in synthesis, delivery, and formulation techniques. The study notes that 48 therapeutic peptides are now on the market worldwide. Four of them have generated global sales of more than $500 million each in 2007. Currently, approximately 400 therapeutic peptides are moving through the clinical trial process.

Development of bioanalytical methods for therapeutic and biomarker peptides is often complicated by their propensity for aggregation, poor solubility, nonspecific binding, and potential instability. These challenges are exemplified in the study of amyloid beta peptides in cerebrospinal fluid as biomarkers in Alzheimer disease (AD) research. To support this challenging work, fast and flexible platforms for peptide quantification are needed that can deliver highly sensitive, reproducible, and accurate results. The use of a single, high-throughput assay for multiple amyloid beta peptides without time-consuming immunoprecipitation steps has been developed and validated, providing researchers with a critical tool to address AD.

This GEN webinar demonstrates the successful implementation of selective sample-preparation techniques used in conjunction with LC/MS for peptide bioanalysis. It will explore in detail some of the challenges that researchers face, particularly in the handling of peptides, when developing successful bioanalytical methodologies for biomarker discovery and peptide drug development.

What Will Be Covered:

• Common challenges associated with handling peptides
• Identifying and addressing pitfalls encountered when developing bioanalytical methods for peptides
• Practical approaches to developing a single LC/MS/MS assay for the simultaneous measurement of multiple peptides in biological matrices
• Guidance on using LC/MS and sample preparation for developing bioanalytical methods for difficult peptides

Panelists Include:

• Rand Jenkins, Scientific Director for Chromatographic Sciences, Pharmaceutical Product Development (PPD)
• Erin Chambers, Principal Applications Chemist, Chemistry Applied Technology, Waters